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Third US biosimilars bill introduced: five years market exclusivity with user fee

Third US biosimilars bill introduced: five years market exclusivity with user fee
Posted 30/07/2009

On 26 March 2009 a third biosimilars bill was introduced in the US by Senators Chuck Schumer, Sherrod Brown, Jeanne Shaheen and Debbie Stabenow, Susan Collins, Mel Martinez and David Vitter. The bipartisan plan would give branded biologicals five years of market exclusivity, up to an additional three years to cover modifications, claiming this will give patients quicker access to cheaper drugs.

“It's past time we created a way for generic versions of these expensive drugs to come to market,” Senator Schumer said. “We have a bipartisan plan that we know consumers will support and we believe the President will too.”

The proposed bill, which is similar to a bipartisan bill introduced in March 2009 by Representative Henry Waxman, would also require companies that want to make generic versions of biologicals to pay a user fee to the US FDA.

The Pharmaceutical Research and Manufacturers of America (PhRMA) does not like this latest bill, nor the Waxman biosimilars bill, saying that such a shortened period of exclusivity would discourage investment in drug development. “Developing biological cures is a complex and difficult undertaking and Congress needs to approach any changes in this arena carefully,” the PhRMA said.

Even less pleased is Biotechnology Industry Organization’s (BIO) Chief Executive, Mr Jim Greenwood: “While well-intentioned, the bill follows Waxman’s proposal through the looking glass to a world of biosimilars that would jeopardise patient safety and undermine future medical breakthroughs,” he said.

Mr Greenwood claimed that the bill “unfairly tilts the playing field towards biosimilars manufacturers” and a successful pathway “must strike the right balance in ensuring patient safety and providing fair, responsible incentives for continued biotech research”. The latest bill “fails to meet this reasonable metric”, he concluded.

PhRMA and BIO prefer a separate biosimilars bill that was introduced in March 2009 by Anna Eshoo, Jay Inslee and Joe Barton. That bill would offer all new biological drugs a base period of 12 years’ data protection, with the right to obtain an additional two years once a further indication for use of the product is approved by the FDA.

By contrast, the Generic Pharmaceutical Association welcomes the latest bipartisan bill. Its Chief Executive, Ms Kathleen Jaeger, said that the proposed legislation “demonstrates that life-saving biogenerics can get to patients in need sooner rather than later while also fostering competition to drive pharmaceutical innovation”.

Ms Jaeger added, “this bipartisan consensus bill holds generic companies to the same quality, safety and science-based standards as brand companies when they make subsequent product changes of their biopharmaceutical medicines. This consensus bill also provides the FDA with the same scientific discretion regarding approval criteria for biogenerics and biosimilars as they have for biopharmaceuticals. There should be one gold standard for science, quality and safety and this legislation provides that standard while also creating a system of market exclusivity that has allowed both the brand and generic industries to flourish together for 25 years to the benefit of consumers.”

According to Ms Jaeger, reducing overall healthcare costs while increasing access to quality care is essential to achieving real healthcare reform. “With studies showing that biogenerics legislation will produce significant savings, it is critical that Congress act to ensure these affordable life-saving medicines get to patients in a timely manner. Momentum is not only growing in Congress, but across the country, with millions of Americans represented by leading consumer, business and labour organisations and AARP supporting this legislation that puts equality into the system and needed medicines into the hands of consumers”, Ms Jaeger said.

Ms Jaeger added that “it's time to enact legislation that gives the FDA the authority and flexibility to create a workable biogenerics approval pathway that upholds their gold standard of ensuring safety and quality”. Ms Jaeger concluded by saying that “we don't need a pathway that's so filled with roadblocks that it is merely an empty promise for patients”.